FDA warns company over unapproved flu remedy
WASHINGTON (AP) — Federal regulators say a Florida company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.
The Food and Drug Administration and the Federal Trade Commission are warning Flu and Cold Defense for making misleading, unproven claims about its GermBullet inhaler.
The Boca Raton, Florida-based company advertises the product as a blend of 11 organic botanicals. It sells the product online and at certain pharmacies and grocery stores.
But government regulators say the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations.
A man reached by phone at Flu and Cold Defense's office could not immediately comment on the warning letter.
The Food and Drug Administration and the Federal Trade Commission are warning Flu and Cold Defense for making misleading, unproven claims about its GermBullet inhaler.
The Boca Raton, Florida-based company advertises the product as a blend of 11 organic botanicals. It sells the product online and at certain pharmacies and grocery stores.
But government regulators say the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations.
A man reached by phone at Flu and Cold Defense's office could not immediately comment on the warning letter.
The FDA has a past history of approving the most toxic criminals known to man, labeling them as safe. Â They have become the strong arm for pharmaceutical companies. They have also become their watchdog, keeping all natural cures off the shelves of our stores. The FDA lost their creditability with the people years ago. The people are no longer concerned if this product is âApproved.â They want to know if it works. Chances are, it does, or it would not be such a threat to the pharmaceutical companies.